Pauline McGregor
Biography
Consulting and Training for analytical laboratories, Global GMPs and Quality Systems.
Areas of expertise are; analytical procedures development, qualification and transfer applying lifecycle and QbD approach; preparing companies for regulatory GMP audits; streamlining an integrated Quality Management System and reducing human error.
| Qualifications |
PhD CChem MRSC |
|---|---|
| Areas of Expertise |
Manufacturing Regulation, health and safety Science, engineering and technology People development |
| Services Offered |
Analytical, forensic and laboratory services Quality assurance and risk management Manufacturing and process development |
| Markets Served | Pharmaceutical and medicinal |
| Geographic Regions Served |
UK North America South America Western Asia |
Contact Pauline McGregor
Additional information
- Auditing of GMP and associated quality systems (Europe, Canada and US regulations)
- Audit observation resolution
- Robust Analytical Method Development, Validation, Transfer
- Risk assessment
- Validation Master Plans
- Validation activities (Analytical, equipment, cleaning, facilities, process, computers)
- Validation documentation
- Analytical Support
- Technical documents (Protocols, Investigations, Reports)
- Technical Consulting
- Quality Investigations to determine root cause and corrective and preventative actions
- Quality Management System set up and management
- External auditor for company self- inspection programs (QA departments)
- Documentation review
- Effective Training Specialist = promotes hands on activities
- Reducing human error
- Pharmaceutical and related industries
- Western Asia: Jordan
- South America: Brazil